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A randomised trial to determine whether CTG monitoring with a computerised decision aide can improve pregnancy outcomes

Indirect quantitative cardiotocography (qCTG) versus indirect standard cardiography plus fetal blood sampling (CTG+FBS) - a randomised comparative study in intrapartum monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46449237
Enrollment
720
Registered
2014-10-02
Start date
2008-03-14
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTG monitoring with a decision aide to reduce Caesarean delivery Pregnancy and Childbirth

Interventions

Participants are randomly allocated to one of two groups: 1. Intervention group receive CTG with an a decision aide 2. Control group receive CTG only (and fetal blood sampling, if necessary)

Sponsors

Second Municipal Hospital for Obstetrics and Gynaecology Sheynovo / Bulgarian Christmas 2007-2011 Charity Initiative (Bulgaria)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women admitted to labour ward who: 1. Were aged 18 years and older 2. Had a singleton pregnancy 3. Had an baby in cephalic position 4. Presented with no ultrasound/laboratory evidence of structural abnormalities of the baby

Exclusion criteria

Exclusion criteria: Women admitted to labour ward who: 1. Were aged <18 years 2. Had multiple gestations 3. Had a baby with an abnormal lie 4. Had a baby with known structural abnormalities as confirmed through ultrasound of laboratory testing

Design outcomes

Primary

MeasureTime frame
1. Occurrence of hypoxia (pH <7.20) 2. Occurrence of acidaemia (pH <7.05) 3. Caesarean delivery 4. Forceps extraction

Secondary

MeasureTime frame
1. Apgar score <7 at 5 minutes 2. Neonatal seizures 3. Admission to NICU All outcomes are immediately after birth with the exception of neonatal seizures and NICU admission. Neonatal seizures and NICU admission are within the first 24 hours after delivery

Countries

Bulgaria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026